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Point of Care Diagnostic Testing Sector Trends
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Description: |
The purpose of this report is to describe the sector trends within the point of care testing (POCT) diagnostic market. It examines those measurement devices and their reagents and supplies that are utilized in hospitals, clinics, commercial laboratories and research institutions to detect cells and proteins for the purpose of diagnosis and monitoring of disease. This study includes all of the generally-accepted clinical analytical activities that are currently in use today. Additionally, an analysis of business and technology trends and developing areas of point of care and HPV testing is provided, along with a review of the market for point of care testing equipment and supplies in the clinical and research market segments, using screening reagents and instruments for analysis of individual components in blood, serum or plasma. This report defines U.S. and global market dollar sales volume and analyzes factors that influence the size and growth of market segments.
The main objectives of this analysis are:
- Identifying viable technology drivers through a comprehensive look at platform technologies for point of care testing. - Obtaining a complete understanding of the chief point of care tests from their basic principles to their applications. - Discovering feasible market opportunities by identifying high-growth applications in different analytical diagnostic areas, focusing on the biggest and expanding markets. - Focusing on global industry development through an in-depth analysis of the major world markets for point of care diagnostic testing technology, including growth forecasts. - Present market figures regarding the current value of the point of care market, projections and growth rates. The source of this information is the most current data derived from the global diagnostic industry.
By purchasing this report, the reader will have:
- An understanding of the most exciting point of care market segments, current and future. - The latest information on leading products and research and development (R&D) initiatives. - Familiarity with recent developments and their effects on selected markets. - Knowledge of the point of care market as an area of growth, research and investment.
Key questions answered in this report:
- How can point of care tools and technologies facilitate other diagnostic tests? - What are the main types of point of care technologies that are currently available? - Who are the current key players in this marketplace? - Which point of care market areas have the greatest potential for growth? - What is the current state of the point of care market? - Which biotechnology and diagnostic companies are investing in point of care solutions? - What are the main point of care business strategies adopted by leading companies? - What are the benefits of point of care technology platforms?
This report contains:
- Detailed analysis of recent trends in the point of care marketplace. - In-depth profiles of the leading companies with point of care tools and technologies. - A five-year forecast for the point of care market in the biotechnology and diagnostic industries. - Views and principles on the point of care industry from leading industry experts. - Analysis of potential point of care applications in the life science sector. - Market predictions and trends analysis concerning U.S. expenditure on point of care solutions. - Projections for future applications of molecular diagnostic tests in point of care related screening. - Analysis of commercial point of care business strategies. - The latest news and developments in the point of care marketplace. - A comprehensive overview and insight into point of care business strategies |
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Contents: |
1. Overview 6 1.1 Statement of Report 6 1.2 Scope of the Report 8 1.3 Objectives 9 1.4 Methodology 9 1.5 Executive Summary 9 2. Overview of Diagnostic Point of Care Testing 11 2.1 Key Issues in the Point of Care Diagnostic Testing Sector 11 2.1.1 Current Market Trends and Drivers 11 2.1.2 Effectiveness of POCT 12 2.1.3 New Growth Areas for POCT 13 2.1.4 Advantages of POCT in a Clinical Setting 13 2.1.5 Pricing and Reimbursement Issues 13 2.1.6 Key Customer Segments 13 2.2 Global Point of Care Marketplace 13 2.3 Shifts from Central-Lab Testing to POCT 15 2.4 Geographical Distribution 15 2.5 Emerging New Technologies 16 2.6 Challenges of POCT 17 2.7 Key Issues for POCT 17 2.7.1 Locations of POCT 17 2.7.2 Hospital Lab Rapid Tests 18 2.7.3 Doctors Office Laboratory 18 2.7.4 Non-Hospital POCT 18 2.7.5 Home Monitoring 19 2.7.6 Milestones in Technology Development 20 2.7.7 Drive for Decentralization from Lab to Patient 20 2.7.8 Expanded Reimbursement 20 2.7.9 Competitive Landscape for POCT 23 2.8 The Future of POCT 23 3. POC and Rapid Testing: Market Analysis: Size, Background, Growth, Share and Competitors 24 3.1 Global POCT Market 26 3.2. U.S. Point of Care Markets 27 3.3. European POCT Market 32 3.4. Japanese POCT Market 35 4. The Place of POCT in Critical Care 36 4.1 Technological Diversity in POCT 36 4.1.1 The Wide Range of Point of Care Assays 36 4.1.2 Challenge of Testing on a Single Platform 39 4.1.3 Connectivity with Testing Platforms 40 4.1.4 Improvement in Clinical Outcomes with Use of POCT 42 4.1.5 Future Developments 42 4.2 Point of Care Addresses Critical Requirements 43 4.2.1 Needs in Critical-Care Testing 43 4.2.2 Point of Care Instrument Key Elements 44 4.2.3 Key Advancements-Menu, Quality Assurance (QA), Connectivity, Internet Access 44 4.2.4 Standardized System for All Testing Locations 45 4.3 POCT Versus Central-Laboratory Testing 47 4.3.1 The Financial Advantages of POCT 47 4.3.2 Is the Shift Towards Point of Care Justified? 47 4.3.3 Overall Cost Benefit 48 4.3.4 More Available Time for Clinical Practitioners 49 4.3.5 Future Policies 49 5. POCT Sector Trends and Forecasts 50 6. Business Trends in the Point of Care Sector 52 6.1 Sector Consolidation 52 6.2 Acquisition, License Agreements, Internal Development and Partnerships 53 6.3 Product Breadth in POCT 54 6.4 Companies Exiting from POCT 54 6.5 Increased Market Penetration 55 6.6 Costs of Doing Business in Europe 56 6.7 Drivers of European Diagnostics Testing 56 6.8 European Reimbursement Practices 56 6.9 Cost Containment in Europe 56 6.10 Significant Factors that Provide Competitive Advantage 57 6.11 Sales and Marketing Strategies for POCT 57 6.11.1 North American Market 57 6.11.2 International Markets 58 6.11.2.1 Europe 59 6.11.2.2 Central and South America 59 6.11.2.3 Asia/Pacific 59 7. Biotechnology Industry Trends 61 7.1 Pharmaceutical Industry Trends 61 7.2 Acquisition, License Agreement and Partnerships 62 8. Government Regulation 65 8.1 Government Regulation 65 8.1.1 U.S. Regulation 65 8.1.1.1 Importing Medical Devices into the U.S. 66 8.1.1.2 Exporting Medical Devices from the U.S. 67 8.1.2 U.K. Regulations 68 8.1.3 E.U. Regulations 69 8.1.4 Japanese Regulations 71 8.1.5 Korean Regulations 71 8.2 Post-Filing Regulations for Point of Care Devices 72 8.3 Exporting Unapproved POCTs 73 8.4 Analyte Specific Reagents (Home-Brew Tests) 73 8.5 Medical Device Registration 73 8.6 Product Labeling 74 8.7 Punitive FDA Actions 74 8.8 Clinical Laboratory Improvement Act of 1988 and State Laboratory Laws 74 8.9 Impact of Regulations on the Industry 75 8.10 Minimizing Regulatory Barriers 76 9. Limited Reimbursements by Third-Party Payers Obstruct Sales 79 9.1 Third-Party Reimbursement Impact on POCT Reagents and Devices Sales 79 9.2 Reimbursement Codes Classification 79 9.3 Point of Care Product Line Reimbursement Picture 80 10. Barriers to Business 81 10.1 Concentration of Customers 81 10.2 Intense Competition from Other Companies 81 10.3 Protection of Intellectual Property Rights 81 10.4 Physician Acceptance 82 10.5 Current Levels of Growth in the Market for Point of Care Diagnostic Testing Procedures May Not be Indicative of Future Growth 82 10.6 Additional Applications of Technology Platform 83 10.7 Management of Growth 83 10.8 Difficulty of Establishing a Marketing Infrastructure 83 11. Acquisition Activity 84 11.1 The Ideal Acquisition Profile 84 11.2 Markets of Interest for Acquisition of POCT 84 11.3 Key M&A Steps 84 12. POCT Manufacturers Corporate Profiles 85 12.1 Abaxis, Inc. 85 12.2 Abbott Diagnostics 86 12.3 Accumetrics, Inc. 89 12.4 Accurex Biomedical, Pvt., Ltd. 90 12.5 ActiMed Diagnostics 90 12.6 Adeza Biomedical Corporation 90 12.7 Akers Bioscience 90 12.8 Ambri, Ltd. 90 12.9 American Biogenetic Sciences, Inc. 91 12.10 American Bio Medica Corp. 91 12.11 Ani Biotech 92 12.12 Apogent Technologies 93 12.13 Ark Therapeutics 94 12.14 Array Medical 94 12.15 Avitar, Inc. 94 12.16 Avox Systems 95 12.17 Axis-Shield 95 12.18 Bayer Corp. 96 12.19 Beacon Diagnostics 98 12.20 Beckman Coulter 99 12.21 Biex, Inc. 102 12.22 Binax Corporation 103 12.23 Biomerica 103 12.24 BioMérieux Vitek, Inc. 103 12.25 BioScan Screening Systems, Inc. 103 12.26 Biosite Diagnostics 103 12.27 BioStar 107 12.28 Bio-Warm Corporation 107 12.29 Caliper Life Sciences 108 12.30 Calypte Biomedical 108 12.31 Cardiovascular Diagnostics 109 12.32 Chembio Diagnostics 110 12.33 ChemTrak 110 12.34 Cholestech 110 12.35 Chongqing Sungene Pharmaceutical Co., Ltd. 111 12.36 CompuCyte Corporation 111 12.37 Cortech, Ltd. 111 12.38 Cozart Bioscience 113 12.39 Cygnus Therapeutic Systems 113 12.40 Cytogen 115 12.41 Dade Behring 115 12.42 Daiichi Co., Ltd. 115 12.43 Denka Seiken Co., Ltd. 115 12.44 Diagnology, Inc. 116 12.45 Diametrics Medical, Inc. 116 12.46 EY Laboratories, Inc. 116 12.47 Enterix, Inc. 116 12.48 First Medical, Inc. 117 12.49 GDS Technology 117 12.50 GenBio 117 12.51 Genzyme Diagnostics 117 12.52 Grant Life Sciences, Inc. 119 12.53 Gryphus Diagnostics, LLC 120 12.54 Helena Laboratories 120 12.55 Hema Diagnostic Systems 120 12.56 HemoCue, Inc. 121 12.57 Home Access Health Corp. 121 12.58 i-STAT Corporation 121 12.59 ImmunoScience, Inc. 122 12.60 Instrumentation Laboratory 122 12.61 International Medical Innovations 123 12.62 Inverness Medical Innovations 123 12.63 Jiangnan Biotech 126 12.64 Johnson & Johnson 126 12.65 Kyowa Medex Co., Ltd. 127 12.66 LifeAssays 127 12.67 LifePoint, Inc. 127 12.68 Lifestream Technologies 130 12.69 LXN Corp. (Inverness Medical Technologies) 130 12.70 Matritech 130 12.71 Medical Services International, Inc. 130 12.72 MediSense 131 12.73 Medisys 131 12.74 Medix Biochemica 131 12.75 MedMira Laboratories 131 12.76 Meretek Corporation 132 12.77 Meridian Bioscience 133 12.78 MiniMed 134 12.79 Mitsubishi Kagaku Iatron 135 12.80 Nanogen 135 12.81 New Horizons Diagnostics 136 12.82 Nova Diagnostics 136 12.83 Optical Sensors, Inc. 138 12.84 OraSure 139 12.85 Orgenics 140 12.86 Orion Diagnostica 140 12.87 PanBio Corp. 141 12.88 PharmaNetics, Inc. 141 12.89 Pharmatech Corporation 141 12.90 Phillips Medical Systems 141 12.91 Point of Care Technologies 142 12.92 Polymedco 142 12.93 Polymer Technology Systems 143 12.94 Princeton BioMeditech Corporation 144 12.95 Quidel 144 12.96 Radiometer 146 12.97 Response Biomedical Corp. 147 12.98 Roche Diagnostics 148 12.99 Royal Philips Electronics 152 12.100 Saliva Diagnostics 152 12.101 Savyon Diagnostics 152 12.102 Selfcare, Inc. 153 12.103 Shanghai Siic Kehua Biotech Co., Ltd. (Kehua Biotech) 153 12.104 Shionogi & Co., Ltd. 153 12.105 SpectRx, Inc. 153 12.106 Spectral Diagnostics 154 12.107 STC Technologies 155 12.108 Sun Biomedical Laboratories 155 12.109 Sybron International Corporation 155 12.110 Taiwan Diagnostic 155 12.111 TCPI 155 12.112 TheraSense, Inc. 157 12.113 Thermo BioStar 157 12.114 Thoratec/International Technidyne Corp. 157 12.115 Transmedica 158 12.116 Trinity Biotech, PLC 158 12.117 Wampole Laboratories 159 12.118 Worldwide Medical Corporation 159 13. FDA Currently-Waived Tests 160 INDEX OF TABLES Table 2.1: POCT Frequency in Hospitals 14 Table 2.2: Worldwide Distribution of IVD Testing 16 Table 2.3: Top-Dozen Country IVD Testing Markets 16 Table 2.4: Competitive Landscape for Point of Care Diagnostic Testing 23 Table 3.1: Number of Emergency Room Visits in U.S. Hospitals, 2000-2008 24 Table 3.2: Number of POCTs in U.S., 2000-2008 24 Table 3.3: The Overall IVD Testing Market Worldwide, 2004 25 Table 3.4: Ten-Largest Diagnostic Companies Worldwide 26 Table 3.5: Global Point of Care Market Size, 1998-2008 27 Table 3.6: Worldwide Distribution of POCT, 2004 27 Table 3.7: U.S. POCT Market, 2000-2011 28 Table 3.8: U.S. Clinical Diagnostic Test Market Segments, Revenue from Clinical Laboratory Testing, 2004 28 Table 3.9: U.S. POCT by Distribution Location, 2004 28 Table 3.10: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 2004 29 Table 3.11: U.S. POCT Glucose-Testing Market Size, 2003-2011 29 Table 3.12: U.S. POCT Blood Gas and Electrolytes Market Size, 2003-2011 30 Table 3.13: U.S. POCT Coagulation Market Size, 2003-2011 30 Table 3.14: U.S. POCT Cardiac Markers Market Size, 2003-2011 30 Table 3.15: U.S. POCT Dedicated Primary Care Markers Market Size, 2003-2011 31 Table 3.16: U.S. POCT Urinalysis Market Size, 2003-2011 31 Table 3.17: Manufacturer Market Share U.S. POCT Market, 2005 31 Table 3.18: Manufacturer Market Share U.S. POCT Market Glucose Testing, 2005 31 Table 3.19: Manufacturer Market Share U.S. POCT Blood Gas and Electrolytes Market, 2005 32 Table 3.20: Manufacturer Market Share U.S. POCT Coagulation Market, 2005 32 Table 3.21: Manufacturer Market Share U.S. POCT Cardiac Marker Market, 2005 32 Table 3.22: Regional Comparison of GDP, Healthcare and IVD for Eastern Europe 33 Table 3.23: European POCT Market, 2000-2008 34 Table 3.24: European POCT Diagnostics Market, 2004 34 Table 3.25: Top-Dozen Country IVD Testing Markets and Point of Care Share, 2004 34 Table 3.26: Japan POCT Market, 2000-2008 35 Table 4.1: Customized Reports Must Support CAP and JCAHO Requirements 41 Table 12.1: Products Marketed by Abbott in the Diagnostic Market, 2003 88 Table 12.2: Quidel Product Sales Distribution, 2003 145 Table 12.3: Key Products 150 |
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